clinical trial · NCT04677569
Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
Mycobacterium Infections, NontuberculousALISAzithromycinEthambutolELC (matching placebo for ALIS)
brief summary
The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin \[AZI\] + ethambutol \[ETH\]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.
started
Apr 1, 2021
primary completion
Nov 21, 2025
completion
Jan 15, 2026
last updated
Feb 3, 2026
official title
ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol